Date & Time
February 18, 2025 | 60-Minute Live Webinar I 15:00 CET
Overview
Post-Market Clinical Follow-up (PMCF) requirements under the EU MDR continue to challenge medical device manufacturers with evolving expectations and rigorous evidence demands. Join us for an exclusive webinar featuring leading experts who will unpack critical PMCF strategies, share real-world survey experiences, and offer insights on bridging data gaps to achieve regulatory success.
Key Learning Objectives
- PMCF from a Notified Body’s Perspective: Understand Notified Body requirements, common pitfalls, and what auditors look for in PMCF planning.
- PMCF Surveys: Best Practices & Compliance: Learn the nuts and bolts of designing robust PMCF surveys, collecting high-quality data, and effectively reporting outcomes that align with MDR expectations.
- Strategic MDR Submissions: Discover how to integrate PMCF findings into broader clinical evidence packages and streamline the regulatory pathway.
- Avoiding Common Pitfalls: Get first-hand insights on how to circumvent frequent PMCF missteps and ensure your data meets regulatory scrutiny.
Agenda at a Glance
- Welcome & Introduction
Speaker: Dr. Nikhil A. Khadabadi
- Planning PMCF: A Notified Body’s Perspective
Speaker: Dr. Ulrich Nitsche (TÜV SÜD)
- PMCF Surveys: Practical Approach for MDR Compliance
Speaker: Marcus Torr (Purdie Pascoe)
- PMCF Strategies: Bridging Data Gaps to Regulatory Success
Speaker: Dr. Nikhil A. Khadabadi (Eclevar MedTech)
- Q&A
Moderator: Dr. Nikhil A. Khadabadi
- Open floor for attendee questions
Why You Should Attend
- Stay ahead of EU MDR requirements and learn directly from a seasoned Notified Body expert.
- Gain actionable insights to design and execute PMCF surveys that meet regulatory scrutiny.
- Learn how to integrate PMCF findings into your clinical and regulatory strategy for seamless MDR submissions.
- Network (virtually) with peers and industry thought leaders and get your PMCF questions answered live.
Meet Our Expert Speakers
Dr. Ulrich Nitsche, MD PhD
Global Director, Clinical Centre of Excellence (TÜV SÜD NB0123 & NB2443)
Ulrich Nitsche MD PhD is Global Director of the Clinical Centre of Excellence, covering all clinicians of the notified bodies TÜV SÜD NB0123 and TÜV SÜD NB2443. Besides his role as an internal clinician, Ulrich is part of Team NB’s Clinical Expert Harmonization Group, active member of the International Organization for Standardization for Clinical Investigations and Clinical Evaluation, and member of the Ethics Committee of the Technical University of Munich. Ulrich Nitsche is a trained visceral surgeon and chief emergency doctor.
Marcus Torr
PMCF Lead at Purdie Pascoe
Marcus joined Purdie Pascoe in 2015, with a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath. Since joining he has rapidly gained experience and skill in quantitative research and has led, and grown, the PMCF team at Purdie Pascoe for the last five years, who provide PMCF survey solutions to the medical device industry to ensure EU-MDR compliance.
He has extensive knowledge in the specific requirements surrounding PMCF surveys, having overseen over 400 surveys for several of the leading global Medical Device manufacturers across a variety device types. These surveys have been approved by several of the leading Notified Bodies and consist of both end user general (Level 8) surveys and high-quality patient specific (Level 4) surveys.
Dr. Nikhil A. Khadabadi, MBBS,MRCS( Edin), MS Ortho
Chief Medical Officer, Eclevar MedTech
A distinguished medical professional with a background in high-risk device evaluations at TÜV SÜD, Dr. Khadabadi now leads global clinical research, regulatory strategy, and PMCF initiatives at Eclevar MedTech. His dual focus on clinical excellence and technological innovation has propelled Milo AI Healthcare’s platform in revolutionizing clinical trials and AI-driven medical decision-making.
Ready to Strengthen Your PMCF Strategy?
Don’t miss this opportunity to gain insider insights from three industry experts. Secure your spot now to learn how to optimize your PMCF approach and navigate the EU MDR with confidence.
